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Reducing Inappropriate Benzodiazepine Use Among Older Adults

Reducing Inappropriate Benzodiazepine Use Among Older Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03405298
Enrollment
44
Registered
2018-01-23
Start date
2018-02-08
Completion date
2018-09-20
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long Term Use of Benzodiazepine

Brief summary

The goal of this project is to reduce chronic benzodiazepine use through two approaches: direct patient education or direct patient education paired with additional support and encouragement from a behavioral health care manager.

Detailed description

This is a State of Michigan/Medicaid Match project proposal. These proposed projects are developed to address specific goals for Medicaid policies, procedures, and model programs for Medicaid Recipients in Michigan. Benzodiazepine use in the United States is common and increases with age, used by 8.7% of patients aged 65-80 years. Benzodiazepines-which include well-known medications such as Xanax, Ativan, and Klonopin-are most commonly used for anxiety and insomnia, even though psychotherapy and alternative medications are now recommended preferentially over benzodiazepines. Use is a particular concern among older adults, given the links between benzodiazepine prescribing and a variety of adverse outcomes including falls, fractures and motor vehicle accidents. Attempts to reduce benzodiazepine use have met with limited success in the real world, as patients are reluctant to consider the possibility of stopping them and providers are reluctant to even suggest the possibility. In the course of a brief return visit in primary care, providers simply do not have the time or incentive to engage in a potentially difficult, lengthy discussion with patients about reducing or stopping their benzodiazepine. The goal of this project is to evaluate direct patient education compared to direct patient education paired with additional support and encouragement from a care manager in order to reduce chronic benzodiazepine use. Strategies to help reduce benzodiazepine use are of great interest to providers and our findings would have significance for all providers, and may even conceivably improve the care of patient both inside and outside the Medicaid program.

Interventions

Educational material is in the form of a brochure

BEHAVIORALSupplemental Collaborative Care

Supplemental care management consist of meeting with a behavioral health care manager over five sessions in-person or via phone call; the care manager will review patient information with the consulting psychiatrist, who can then make recommendations back to the primary care provider

Sponsors

Michigan Department of Health and Human Services
CollaboratorOTHER
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* With a prescription BZD supply covering ≥20% of days in the preceding 12 months (chronic).

Exclusion criteria

* Patients with BZD supply \<20% days in past 12 months * Patients with ICD-10 codes for dementia (derived from encounter diagnosis codes) * long-term care residents (ICD-10 codes Z59.3 and Y92.199)

Design outcomes

Primary

MeasureTime frameDescription
Change in avg. daily dose of benzodiazepine prescribed in lorazepam-equivalent mg3 monthsCompare the average daily dose during month 3 to the baseline average daily dose

Secondary

MeasureTime frameDescription
Generalized Anxiety Disorder 7-Item Scale (GAD-7)3 monthsThe GAD-7 total score ranges from 0 (low) to 21 (high), with cut scores for mild (5), moderate (10), and severe anxiety (15); will be conducted at 3 months.
Insomnia Severity Index (ISI)3 monthsISI is a valid and sensitive measure to detect changes in perceived sleep difficulties, ranging from 0-28. Scores of 0-7 are categorized as no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia (moderate severity), 22-28 clinical insomnia (severe).
Alcohol Use Disorders Identification Test (AUDIT-C)3 monthsHazardous Alcohol Use will be assessed using the AUDIT-C which assesses average alcohol consumption (quantity and frequency) and binge drinking (6 or more) over the past 3 months on a scale of 0 (none) to 12 (heavy alcohol use).The cut-off scores for hazardous drinking are 3 for women and 4 for men.
Patient Health Questionnaire (PHQ-8)3 monthsThe PHQ-8 is a self-report instrument assessing 8 DSM-IV symptoms of depression, this measure will be conducted at 3 months, with total scores ranging from 0 (low) to 24 (high); scores ≥10 suggest the presence of Major Depressive Disorder.
GAD-76 monthsThe GAD-7 total score ranges from 0 (low) to 21 (high), with cut scores for mild (5), moderate (10), and severe anxiety (15).
ISI6 monthsISI is a valid and sensitive measure to detect changes in perceived sleep difficulties, ranging from 0-28. Scores of 0-7 are categorized as no clinically significant insomnia, 8-14 subthreshold insomnia, 15-21 clinical insomnia (moderate severity), 22-28 clinical insomnia (severe).
AUDIT-C6 monthsHazardous Alcohol Use will be assessed using the AUDIT-C which assesses average alcohol consumption (quantity and frequency) and binge drinking (6 or more), this measure will be conducted at 6 months, on a scale of 0 (none) to 12 (heavy alcohol use).The cut-off scores for hazardous drinking are 3 for women and 4 for men.
PHQ-86 monthsThe PHQ-8 is a self-report instrument assessing 8 DSM-IV symptoms of depression, this measure will be conducted at 6 months, with total scores ranging from 0 (low) to 24 (high); scores ≥10 suggest the presence of Major Depressive Disorder.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026